Sec. 10.10.13.15. Test Blood-Spot Specimens — Use, Research, Storage, and Retention

A. Use. A permittee may use a newborn infant blood-spot specimen from a newborn infant to test for only the conditions listed in Regulation .12C of this chapter.

B. Research. A researcher may not use a Maryland newborn infant’s blood spot specimen or test results for research purposes unless the:

(1) Research is approved in writing by the Department's:

(a) Newborn Screening Program; and

(b) Institutional Review Board; and

(2) Researcher acknowledges in writing that the researcher will return all untested blood-spot specimens to the Department’s public health laboratory within 6 months of completing the approved research.

C. Storage. A permittee or researcher shall store a newborn infant blood-spot specimen in a sealed, moisture-proof container at between 2ºC and 6ºC.

D. Retention.

(1) A permittee shall:

(a) Retain a newborn infant’s gel, produced when testing for hemoglobin disorders, for at least 90 days after testing is complete; and

(b) Return to the State’s public health laboratory all untested blood-spot specimens received from the Department’s public health laboratory for supplemental or diagnostic testing within 90 days after testing is completed by the permittee.

(2) The Department’s public health laboratory shall retain and maintain for 25 years a newborn infant’s blood-spot specimen after the blood-spot specimen is received for screening, supplemental testing, or diagnostic testing.